Senior Manager/Associate Director, Drug Substance CMC - HYBRID

Proclinical is seeking a Senior Manager/Associate Director, Drug Substance CMC for a clinical stage biopharmaceutical company.

This role will be responsible for managing CMC-related manufacturing activities and execution of the plan for drug substances from clinical through commercial development. This position is hybrid, with an expected 2 days per week onsite in Redwood City, CA.

Must be eligible to work in the US.

Job Responsibilities:

• Follow and execute the company's CMC development plan for drug substances and drug products from preclinical through commercial development.
• Work with third-party manufacturers in unison with the Quality and Regulatory.
• Assist in identify contract manufacturing and analytical laboratory sites required to guide and support third party manufacturing relationships.
• Oversee contract manufacturing, testing, packaging and labeling operations for the company's drug substances. Act as primary liaison with contractor(s) on assigned projects. Guide external operations through tech transfer, process and method development, optimization, qualification and validation of the activities related to all manufacturing operations.
• Participate in product development project teams as CMC functional area representative.
• Collaborate with Supply Chain and Quality on the disposition and logistics of regulatory starting materials and drug substance shipments.
• Work with Regulatory, QA and Senior Management to ensure that all company policies are adhered to and all external manufacturing activities comply with relevant regulations.
• Maintain knowledge of current best practices of pharmaceutical manufacturing. Identify emerging trends and technologies and lead implementation/feasibility assessment as appropriate.
• Assist in preparing CMC regulatory filing sections (domestic and international) working with Regulatory and Quality.
• Review and approve master and executed batch records from all manufacturing activities; analytical release testing, stability studies and investigations, as required.
• Execute production plans to support preclinical, clinical, and commercial development and adjust plans as appropriate to meet corporate objectives.

Skills and Requirements:

• BA or Master's degree in chemical engineering, chemistry, organic chemistry, or a related scientific discipline.
• Minimum of 7 years' experience. Experience must include small molecules in a pharmaceutical or biotechnology environment.
• Background in outsourced drug substance clinical development through commercialization is required, as is experience in outsourced development through commercialization of solid oral dosage forms, modified-release formulations, and pediatric formulations.
• Experience in managing US CRO/CMOs for the manufacture of cGMP drug substances and drug products; experience collaborating with international CROs/CMOs a plus.
• Knowledge of GMP quality systems.
• Excellent written and verbal communication skills.
• Experience in leading a small molecule manufacturing process and analytical development.
• Experience in achieving regulatory approval of new drugs or biologicals.

If you are having difficulty in applying or if you have any questions, please contact Eloise Coly at (+1) 617-830-1627 or e.coly@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.